Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Friday, March 25, 2011

The Institute of Medicine Releases Reports on Practice Guidelines and Systematic Reviews Which Generate Few Echoes

Two days ago, the prestigious US Institute of Medicine released two reports on important health care issues, clinical practice guidelines and systematic reviews. Systematic reviews of the relevant clinical research have been advocated by evidence-based medicine proponents as the appropriate basis for clinical and policy decisions. Clinical practice guidelines have been advocated by many health researchers, policy makers, and clinicians as the best way to encapsulate the evidence to inform clinical and policy decision making. Both reports suggested series of standards for how systematic reviews and clinical practice guidelines should be developed.

These topics are of general importance to clinicians, health services researchers, and health policy makers. The Institute of Medicine, part of the US National Academy of Sciences, is one of the most authoritative sources of opinion on medicine and health care. Therefore, one would think that these reports would have gotten wide notice, and would hardly required Health Care Renewal to create some echoes.

However, a Google News search today produced only six "hits" relevant to these reports, including the original press release. All are in specialized medical/ health care news outlets. None are in the national media, and none are from major medical/ professional journals or societies.

Let me suggest a theory about why these two major reports have generated so few echoes so far. Let me quote from the summary of the report on clinical practice guidelines:

Most guidelines used today suffer from shortcomings in development. Dubious trust in guidelines is the result of many factors, including failure to represent a variety of disciplines in guideline development groups, lack of transparency in how recommendations are derived and rated, and omission of a thorough external review process. To be trustworthy, clinical practice guidelines should:
• Be based on a systematic review of the existing evidence;
• Be developed by a knowledgeable, multidisciplinary panel of experts and representatives from key affected groups;
• Consider important patient subgroups and patient preferences, as appropriate;
• Be based on an explicit and transparent process that minimizes distortions, biases, and conflicts of interest;
• Provide a clear explanation of the logical relationships between alternative care options and health outcomes, and provide ratings of both the quality of evidence and the strength of recommendations; and
• Be reconsidered and revised as appropriate when important new evidence warrants modifications of recommendations.
Additionally, as reflected in the committee’s standards for developing trustworthy clinical practice guidelines, guideline development groups optimally comprise members without conflict of interest. The committee recognizes that in some circumstances, a guideline development group may not be able to perform its work without members who have conflicts of interest—for example, relevant clinical specialists who receive a substantial portion of their incomes from services pertinent to the guideline. Therefore, the committee specifies that members of the guideline development group who have a conflict of interest should not represent more than a minority of the group.

So it seems that the report on clinical practice guidelines emphasized two issues highly relevant to Health Care Renewal, the need for transparency in guideline development, and the need to avoid conflicts of interest affecting the development process. The two first standards for guidelines are about transparency and minimization of conflicts of interest. Similarly, the report on systematic reviews also included fairly tough standards to minimize conflicts of interest.

We on Health Care Renewal go on and on about the need to maximize transparency in health care, and particularly in health care leadership and governance, and about the need to disassemble the now pervasive web of conflicts of interest that has entangled health care. However, as we know, these are not popular topics among the leadership of health care, which includes many individuals who have greatly benefited from lack of transparency and pervasive conflicts of interest. We know these topics make these leaders, and many of those who report to, or work or associate with them very uncomfortable.

So unfortunately, I am not surprised that the two new and likely authoritative reports from the Institute of Medicine, despite that organization's prestige, have started off relatively anechoic. It also unfortunately likely that they will remain relatively anechoic.

In 2009, the IOM issued an authoritative report on conflicts of interest in medicine and health care which suggested fairly tough standards to decrease such conflicts and their influence (also see post here). Since 2009, I just found 53 citations to that report in the medical literature using the ISI Web of Science, for a rate of 27/year. In 1999, the IOM issued a report on medical errors, "To Err is Human." Since then, it has received 1374 citations, a rate of 115/year.

As we noted above, the topic of conflicts of interest seems to make the powers that be in health care very uncomfortable. In contrast, "To Err is Human" was widely interpreted to mean that physicians make a lot of dangerous errors, and the best way to decrease them is to impose more controls by bureaucrats, managers, and executives (even if that was not its intent). Thus, that report could be twisted to fit the talking points of the powers that be, and hence has been anything but anechoic.

So while Health Care Renewal is hardly a powerful tool for creating publicity, I thought we should try to get the word out about the new IOM reports on clinical practice guidelines and systematic reviews. Every little bit helps.

Meanwhile, the deathly quiet reception these reports have gotten so far emphasizes the need to combat the anechoic effect. As long as the powers that be can command billions of dollars to influence the health care conversation through their marketing, public relations, and lobbying departments, expect the discussion not to question what they do, and how they benefit from the status quo to the financial and health detriment of patients and the population.

We will not be able to truly reform health care until we can speak openly about what threatens health care values and what needs to be done about these threats.

6 comments:

Yes, can't malign clinicians with these reports, so they're just not popular.

I opine that systematic reviews and practice guidelines in the domain of health IT will be very popular.

That is, as long as they show positive results and ignore the downsides, like the recent "systematic-ish" review article by the ONC in Health Affairs that I wrote about, and the results I expect from upcoming IOM HIT safety study.

I really don't think reporters understand even how to read such reports and what the implications are.

It took me a while to understand how to read between the lines of medico-academic papers, reports, and understand a 'body of literature.' Plus it takes time many simply do not have the time to invest. Plus there will also be others pushing a different take on the same source material.

I have first hand experience explaining things to reporters, lawyers and lay folk in general (and the reverse translation of the world to MDs and PhDs).

It isn't easy to provide them a translation they can understand and sink their teeth into. It helps a lot to envision the things others will say and counter it before hand, as in "some may say but that isn't credible because of ."

It is a process that requires more than a few sessions where misinterpretations (often caused by others) are corrected.

Sometimes you have to point to the red meat if not serve it up prepared with side dishes and accoutrements of other reference information.

It makes some sense to me that these new IOM reports support the goal of federal regulation of clinical practice guideline development. It flows logically (though not necessarily in the correct order) from the notion that healthcare IT should be federally regulated. Ideally, healthcare IT should support the meaningful use of evidence-based clinical guidelines. So, I'm quite surprised we didn't see these IOM reports come out a year or two ago.

Are there any conflicts of interest, or bias, inherent programs that allow the federal government to regulate healthcare?I would be very interested in learning the steps that will be taken to reduce the amount of bias and conflicts of interest in clinical guideline development workgroups. Aren't a lot of highly qualified people for these workgroups going to have likely conflicts of interest that come with professional success? I wouuld even venture to beg the question: Aren't most of these people going to have significant conflicts of interest? Or bias? These are people we're talking about here.

The pharmaceutical (and probably biotech, device, and health care IT) industry would love to have us believe that they only use the best and the brightest as consultants, speakers, etc. Hence, they would like us to believe that if we want the best and the brightest on the guideline panels, we will have to accept those who have financial ties to the companies that make products or provide services relevant to the guidelines' topics.

There is considerable anecdotal evidence, however, that these companies pick as key opinion leaders who will be most helpful in marketing their products. See here:http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders

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